NCT02351778

Brief Summary

In study the investigators sought to

  1. 1.Assess the quality of life experience in stable post stroke survivors in Pakistan and detail important factors influencing quality of life.
  2. 2.Explore the association between primary care giver's quality of life and stroke survivor's quality of life.
  3. 3.To validate the quality of life tools and experience via in depth interviews and focus group discussion with the primary care giver of stroke patients to report the quality of life of the primary care giver.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

January 28, 2015

Last Update Submit

January 29, 2015

Conditions

Keywords

Developing CountriesQuality of LifeMixed MethodsValidationCaregiver Burden

Outcome Measures

Primary Outcomes (1)

  • Quality of life of stroke survivors evaluated by stroke specific quality of life scale one month post stroke

    Stroke Specific Quality of Life Scale

    12 Months

Secondary Outcomes (1)

  • Quality of life of primary care givers of stroke survivors evaluated by RAND-36

    12 Months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All men and women greater than 18 years, with a chronic stable stroke, medically confirmed supported by medical reports or radiological and neurological diagnosis and with an identified primary care giver.

You may qualify if:

  • All men and women of age greater than 18 years of age with medically confirmed diagnosis of stroke.
  • Suffered stroke (3 months till 12 months), stable non fluctuating stroke which means no acute ongoing neurologic developments (Crescendo TIA, CEA planned, intervention needed, progressing stroke, fluctuating unexplained neurologic symptoms).
  • With an identified primary care giver (This is a person who lives with the stroke patient, is familiar with the medical history and provides direct care e.g. feeding support, medication reminders, rehab. This person may be different from the legal surrogate e.g., son vs. daughter in law )

You may not qualify if:

  • Post procedure stroke like CABG, angiography, post-operative.
  • Global aphasia with failure to communicate (NIHSS greater than 23).
  • Dementia with failure to communicate (Minimental state of 22)
  • With history of psychoactive substance abuse.
  • Psychiatric morbidity like schizophrenia and other manic disorders.
  • Suffering from chronic disease like terminal stage cancer and end stage renal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Khalid W, Rozi S, Ali TS, Azam I, Mullen MT, Illyas S, Un-Nisa Q, Soomro N, Kamal AK. Quality of life after stroke in Pakistan. BMC Neurol. 2016 Dec 3;16(1):250. doi: 10.1186/s12883-016-0774-1.

MeSH Terms

Conditions

Cerebrovascular DisordersCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Neurology,Director Stroke Fellowship Program

Study Record Dates

First Submitted

January 28, 2015

First Posted

January 30, 2015

Study Start

January 1, 2014

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

January 30, 2015

Record last verified: 2015-01